Toxicity issues

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well docetaxel works in treating older women with metastatic breast cancer and whether it helps improve the ability to perform daily activities.

OBJECTIVES:

Primary

• Determine degree of autonomy in instrumental activities of daily living on-therapy and at 6 and 12 months, as measured by Lawton's Instrumental Activities of Daily Living Scale, in older women with metastatic adenocarcinoma of the breast treated with docetaxel.

Secondary

• Determine the response rate in patients treated with this drug.
• Determine overall and progression-free survival of patients treated with this drug.
• Determine the degree of autonomy in daily activities as measured by Katz's Activities of Daily Living Scale, in patients treated with this drug.
• Determine mood status, as measured by the Geriatric Depression Scale, of patients treated with this drug.
• Determine toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive docetaxel IV on days 1 and 15. Treatment repeats every 28 days for 6 courses.

Ability to perform daily activities is assessed periodically.

PROJECTED ACCRUAL: A total of 53 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the breast

  • Metastatic disease

• Measurable disease by CT scan or MRI

• Requires first-line chemotherapy for metastatic disease

• Hormone receptor status:

  • Not specified

PATIENT CHARACTERISTICS:

Age

• 70 and over

Sex

• Female

Menopausal status

• Not specified

Performance status

• Meets both of the following criteria:

  • Lawton's Instrumental Activities of Daily Living score ≥ 4
  • Katz's Activities of Daily Living score ≥ 4

Life expectancy

• More than 3 months

Hematopoietic

• Hemoglobin > 10 g/dL
• Neutrophil count > 1,500/mm^3
• Platelet count > 100,000/mm^3

Hepatic

• ALT and AST < 1.5 times normal
• Bilirubin normal
• Alkaline phosphatase < 2.5 times normal

Renal

• Creatinine clearance > 30 mL/min

Cardiovascular

• No congestive heart failure
• No unstable angina pectoris
• No myocardial infarction within the past year
• No uncontrolled hypertension
• No high-risk uncontrolled arrhythmias

Other

• Geriatric Depression Score < 12
• No active uncontrolled infection
• No active peptic ulcer
• No uncontrolled diabetes mellitus
• No inflammatory bowel disease
• No history of hypersensitivity to docetaxel or drugs formulated with polysorbate 80
• No history of significant neurologic or psychiatric disorders, including psychotic disorders, dementia, or seizures, that would preclude giving informed consent
• No familial, social, geographical, or psychological condition that would preclude study follow-up
• No definite contraindication to corticosteroids
• No other serious illness or medical condition
• No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior or concurrent trastuzumab (Herceptin^®)

Chemotherapy

• Prior neoadjuvant or adjuvant chemotherapy for breast cancer allowed
• More than 2 years since prior docetaxel or paclitaxel
• No other concurrent chemotherapy

Endocrine therapy

• No more than 1 prior hormonal therapy regimen for metastatic disease

• At least 10 days since prior hormonal therapy

• No concurrent hormonal therapy

• No concurrent chronic corticosteroids

  • Concurrent low-dose corticosteroids (≤ 20 mg/day of methylprednisolone or equivalent) allowed provided treatment was initiated > 6 months before study entry

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• More than 30 days since prior active treatment on another clinical trial
• Concurrent bisphosphonates allowed for bone metastases, osteoporosis, or osteopenia
• No other concurrent anticancer therapy
• No other concurrent investigational drugs